Management Scientific Board Quality Assurance Unit Chemistry Department Formulation Manufacturing Department Minisynthesis Department Pharmacology Department Pharmacy Department Pilot Plant Department Quality Control and Research Analytics Department


  ORGANIZATION DRAFT > PILOT PLANT DEPARTMENT

Centrifuge
Photo gallery

The Pilot Plant Department develops novel processes for the active pharmaceutical ingredients (API) manufacturing, including documentation preparation, adaptation of laboratory or small scale syntheses (scale-up), process optimization and validation. It also produces several APIs in Drug Substance Synthesis Installation, which was completely rebuilt in the years 2005-2007. Modern equipment and technological installations are fully compliant with the European pharmaceutical requirements.
The technological process is controlled and documented in accordance with Good Manufacturing Practice (GMP) rules. The final steps of API manufacturing are performed in the grey controlled area, where 3 purification and 2 process lines are situated.

Our services include:

  1. Development of the preliminary process schemes.
  2. Development of the active pharmaceutical ingredient (API) manufacturing processes, including new polymorphic forms.
  3. API manufacturing technology implementation.
  4. API manufacturing (batch size 5-100 kg).
  5. R&D manufacturing of active pharmaceutical ingredients in accordance with GMP rules for domestic and foreign companies.
  6. Preparation of manufacturing process documentation in accordance with GMP rules.

Key equipment of the Pilot Plant Department:

Reactor
Chemical reactor in the syntheses area
  • accommodation:
    • grey controlled area of 210 m2
    • synthesis area of 600 m2
    • analytical laboratory of 36 m2
    • warehouse of 250 m2
    • technical area of 250 m2
    • offices of 130 m2
  • process equipment:
    • enamel reactors set (reactor, filter, reactor, cooler, receptacle) from 50 dm3 to 1600 dm3 of capacity
    • sediment separation equipment (centrifuges, pressure filters, vacuum nutsche filters)
    • fluid, vacuum and air dryers
    • blenders, mixers
  • systems and installations:
    • ventilation and air conditioning system
    • technological installations: water, heating steam, cooling, compressed nitrogen and air, vacuum
  • Photo gallery of Pilot Plant Department's key equipement

Staff:

  • Scientific staff - 7 persons
  • Technical staff - 13 persons

 Head:  Ryszard Modzelewski, M.Sc.
 Phone:  (+48 22) 456 38 43
 Fax:  (+48 22) 456 38 38
 E-mail: